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MX2022012136A - Methods for characterizing low-abundance host cell proteins. - Google Patents

Methods for characterizing low-abundance host cell proteins.

Info

Publication number
MX2022012136A
MX2022012136A MX2022012136A MX2022012136A MX2022012136A MX 2022012136 A MX2022012136 A MX 2022012136A MX 2022012136 A MX2022012136 A MX 2022012136A MX 2022012136 A MX2022012136 A MX 2022012136A MX 2022012136 A MX2022012136 A MX 2022012136A
Authority
MX
Mexico
Prior art keywords
hcp
impurities
host cell
abundance
methods
Prior art date
Application number
MX2022012136A
Other languages
Spanish (es)
Inventor
Ning Li
Hui Xiao
I - Hsuan CHEN
Original Assignee
Regeneron Pharma
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Regeneron Pharma filed Critical Regeneron Pharma
Publication of MX2022012136A publication Critical patent/MX2022012136A/en

Links

Classifications

    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/68—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving proteins, peptides or amino acids
    • G01N33/6803—General methods of protein analysis not limited to specific proteins or families of proteins
    • G01N33/6848—Methods of protein analysis involving mass spectrometry
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N30/00—Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography or field flow fractionation
    • G01N30/02—Column chromatography
    • G01N30/62—Detectors specially adapted therefor
    • G01N30/72—Mass spectrometers
    • G01N30/7233—Mass spectrometers interfaced to liquid or supercritical fluid chromatograph
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/68—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving proteins, peptides or amino acids
    • G01N33/6803—General methods of protein analysis not limited to specific proteins or families of proteins
    • G01N33/6845—Methods of identifying protein-protein interactions in protein mixtures
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/68—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving proteins, peptides or amino acids
    • G01N33/6854—Immunoglobulins
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N30/00—Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography or field flow fractionation
    • G01N30/02—Column chromatography
    • G01N30/88—Integrated analysis systems specially adapted therefor, not covered by a single one of the groups G01N30/04 - G01N30/86
    • G01N2030/8809—Integrated analysis systems specially adapted therefor, not covered by a single one of the groups G01N30/04 - G01N30/86 analysis specially adapted for the sample
    • G01N2030/8813—Integrated analysis systems specially adapted therefor, not covered by a single one of the groups G01N30/04 - G01N30/86 analysis specially adapted for the sample biological materials
    • G01N2030/8831—Integrated analysis systems specially adapted therefor, not covered by a single one of the groups G01N30/04 - G01N30/86 analysis specially adapted for the sample biological materials involving peptides or proteins
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2458/00—Labels used in chemical analysis of biological material
    • G01N2458/15—Non-radioactive isotope labels, e.g. for detection by mass spectrometry
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2560/00—Chemical aspects of mass spectrometric analysis of biological material
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N30/00—Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography or field flow fractionation
    • G01N30/02—Column chromatography
    • G01N30/62—Detectors specially adapted therefor
    • G01N30/72—Mass spectrometers

Landscapes

  • Life Sciences & Earth Sciences (AREA)
  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Molecular Biology (AREA)
  • Immunology (AREA)
  • Physics & Mathematics (AREA)
  • Chemical & Material Sciences (AREA)
  • Hematology (AREA)
  • Biomedical Technology (AREA)
  • Urology & Nephrology (AREA)
  • General Physics & Mathematics (AREA)
  • General Health & Medical Sciences (AREA)
  • Biochemistry (AREA)
  • Analytical Chemistry (AREA)
  • Pathology (AREA)
  • Bioinformatics & Computational Biology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Microbiology (AREA)
  • Medicinal Chemistry (AREA)
  • Food Science & Technology (AREA)
  • Cell Biology (AREA)
  • Biotechnology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Biophysics (AREA)
  • Spectroscopy & Molecular Physics (AREA)
  • Other Investigation Or Analysis Of Materials By Electrical Means (AREA)
  • Peptides Or Proteins (AREA)
  • Investigating Or Analysing Biological Materials (AREA)
  • Preparation Of Compounds By Using Micro-Organisms (AREA)
  • Measuring Or Testing Involving Enzymes Or Micro-Organisms (AREA)

Abstract

The present application provides methods and systems to identify host cell protein (HCP) impurities in a sample containing high-abundance proteins. The HCP impurities can be enriched using interacting peptide ligands which have been attached to solid support. The HCP impurities can be eluted from the solid support using solution containing phase transfer surfactants. The isolated HCP impurities can be digested to generate components of the isolated HCP impurities which can subsequently be identified using a mass spectrometer.
MX2022012136A 2020-03-30 2021-03-30 Methods for characterizing low-abundance host cell proteins. MX2022012136A (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US202063001690P 2020-03-30 2020-03-30
US202063031336P 2020-05-28 2020-05-28
PCT/US2021/024919 WO2021202554A1 (en) 2020-03-30 2021-03-30 Methods for characterizing low-abundance host cell proteins

Publications (1)

Publication Number Publication Date
MX2022012136A true MX2022012136A (en) 2022-10-18

Family

ID=75888145

Family Applications (1)

Application Number Title Priority Date Filing Date
MX2022012136A MX2022012136A (en) 2020-03-30 2021-03-30 Methods for characterizing low-abundance host cell proteins.

Country Status (11)

Country Link
US (2) US12007396B2 (en)
EP (1) EP4127729A1 (en)
JP (1) JP2023519961A (en)
KR (1) KR20220160017A (en)
CN (1) CN115698722A (en)
AU (1) AU2021248795A1 (en)
BR (1) BR112022018938A2 (en)
CA (1) CA3176446A1 (en)
IL (1) IL296787A (en)
MX (1) MX2022012136A (en)
WO (1) WO2021202554A1 (en)

Families Citing this family (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP4348258A1 (en) * 2021-06-04 2024-04-10 Genentech, Inc. Identification and quantitation of residual host cell proteins in protein samples
IL314117A (en) * 2022-01-10 2024-09-01 Regeneron Pharma Improved sequence variance analysis by proteominer
WO2024249327A1 (en) * 2023-05-26 2024-12-05 Pierce Biotechnology, Inc. Methods and compositions for analyzing host cell proteins
WO2024263520A1 (en) * 2023-06-19 2024-12-26 Regeneron Pharmaceuticals, Inc. Host cell protein analysis for adeno-associated virus (aav)-based gene therapy
CN117192107A (en) * 2023-09-11 2023-12-08 福建基诺厚普生物科技有限公司 Detection method and kit for process-specific host cell protein residues

Family Cites Families (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US1522343A (en) 1923-05-02 1925-01-06 Thom Clarence Magnetic separator
US7087411B2 (en) 1999-06-08 2006-08-08 Regeneron Pharmaceuticals, Inc. Fusion protein capable of binding VEGF
US9453845B2 (en) * 2010-02-01 2016-09-27 Cell Signaling Technology, Inc. Mass spectroscopy analysis of mutant polypeptides in biological samples
US20190169675A1 (en) * 2016-08-12 2019-06-06 Lonza Ltd Proteomic analysis of host cell proteins

Also Published As

Publication number Publication date
EP4127729A1 (en) 2023-02-08
CN115698722A (en) 2023-02-03
BR112022018938A2 (en) 2022-12-06
WO2021202554A1 (en) 2021-10-07
CA3176446A1 (en) 2021-10-07
JP2023519961A (en) 2023-05-15
AU2021248795A1 (en) 2022-10-27
KR20220160017A (en) 2022-12-05
US12007396B2 (en) 2024-06-11
IL296787A (en) 2022-11-01
US20240280584A1 (en) 2024-08-22
US20210302433A1 (en) 2021-09-30

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